Quality Assurance and Quality Improvement Program

The Quality Assurance (QA) component of the Florida Atlantic University Human Research Protection Program (HRPP) evaluates the current practices of the IRB and Florida Atlantic research community against defined standards and best practices of the Office of Human Research Protections (OHRP), FDA, State of Florida, and institutional policy and process. The purpose of this program is to assess research activities conducted under and in accordance with the University’s Federal Wide Assurance Agreement with OHRP.

Visits will occur bi-annually and are intended to be collegial. These visits are an opportunity for researchers to request any help they may need, and to provide feedback on the protocol process. Protocols may selected randomly or for-cause if warranted.

Identifying Projects for Random Review

• Include IRB approved protocols in which subjects have been enrolled or identifiable data have been obtained.
• May include Exempt, Expedited, or Greater than Minimal Risk protocols.
• May include funded projects or unfunded projects.

Identifying Projects for For-Cause Review

• The reviews can be requested by the Florida Atlantic IRB, the Vice President for Research or the University Compliance Officer.
• The reviews are typically implemented due to unusual circumstances, significant risks to subjects, routine failure of an investigator to comply with federal and/or institutional requirements, allegations or concerns about the conduct of the study brought to the IRB’s attention, or any case requiring further scrutiny as deemed appropriate.

Reviewers may ask to see a number of items during the visit. Areas include the following:

• Recruitment & Compensation
• Subject Inclusion and Enrollment
• Informed Consent (Content and Process)
• Data Collection, Storage, Transmittal, Destruction, and Security
• Adverse Events
• Project Personnel (Qualifications and IRB Training)
• Amendments
• Protocol Adherence (Violations/Deviations)
• Other areas as determined by the review

• Know and observe applicable federal regulations, state law and institutional SOPs and/or policies.
• Know and follow the IRB-approved protocol.
• Know the study-related roles and responsibilities of the principal investigator and other research team members. Review the protocol with the research team members, identify and discuss any concerns or questions regarding conduct of the study. Ensure that each research team member has access to the most current documents, including, but not limited to, the informed consent document, protocol, and case report forms.
• Differentiate between the study-related and healthcare provider roles and responsibilities.
• Create and use tools to assist in the compliant conduct of the study (worksheets, data collection forms, logs, checklists, etc.).
• Develop and maintain an effective system for data collection and storage.
• Implement quality assurance measures to ensure your study is conducted in accordance with the IRB approved protocol, institutional policy, and required regulations.